Life Sciences Automated Environmental Monitoring Systems: Regulations and Guides

Focused on key applications and following Quality by Design (QbD) principles, we continue to invest in the development of digital engineered solutions (DES) to aid GMP, regulatory compliance and efficiency optimization and help reduce capital project execution costs, risks and time to market, as well as offering services that help lower operational expenditure.

Proof that pharmaceutical ingredients and products have been made correctly and are safe to use is reliant on trustable data from the manufacturing process and its supply chain. The Data Integrity ALCOA+ concept defines best practice guidelines and methodologies for good data management within life science industries. This paper gives an overview of the ALCOA+ concept, its role within the digital transformation of the Life Science Industry, and offers a view on data acquisition and management solutions that help achieve the required data integrity

Temperature continues to play an important role in the development of new medical equipment, biotechnology and clinical diagnostic instrumentation. With 50 years’ experience in the Life Science industries, Watlow® is a leader in breaking new ground in designing, manufacturing and supporting innovative thermal solutions to meet medical advancements and new industry requirements. Leading medical equipment manufacturers rely on Watlow solutions for their patientcare equipment, surgical devices and biotechnology and clinical diagnostic instrument application needs.


Greater temperature responsivenessAccurate temperature control of critical processesLow leakage current complianceReduced cost, space and device weightSuperior temperature measurementLower heater mass and temperature uniformityFaster processing timesReduction in moving partsProduct miniaturization

Eurotherm provide a range of products, engineered solutions and services throughout the world. We can help to solve your manufacturing challenges:Development cost and time to market (data analytics and knowledge management)Constraints linked compliance (Quality by Design)Improving process efficiency (through quality and cost control)Adapting to patient centred care (personalised medicines)Target carbon neutrality 

ISPE guidance suggests considering the segregation of the Building management system (BMS) and the Environmental monitoring system (EMS). Segregating the control system (BMS) from the monitoring system (EMS) enables significant savings, in fact: qualification documentation and execution challenges apply to EMS only, change control and risk assessment activities are not required for modification to the BMS, periodic calibration routines are limited to the EMS, record management is limited to the EMS critical parameter data and its contextual metadata.